Roland J Thomas, Gantz Bruce J, Waltzman Susan B, Parkinson Aaron J
Department of Otolaryngology-Head and Neck Surgery, NYU School of Medicine, New York, New York.
Department of Otolaryngology-Head and Neck Surgery, the University of Iowa, Iowa City, Iowa.
Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13.
To demonstrate the long-term benefits of implantation in patients with high-frequency sensorineural hearing loss, this report provides 5-year follow-up on a group of implant recipients who were subjects of the Cochlear™ Nucleus Hybrid™ L24 Implant System pivotal clinical study.
The results of three related clinical studies were compiled to provide outcome data after 1, 3, and 5 years of implant use in a group of subjects who presented with preoperative high-frequency hearing loss and were implanted with a Nucleus Hybrid L24 (Cochlear Ltd., Sydney, Australia) cochlear implant. A subset of the 50 adult subjects (N = 32) who participated in the Hybrid L24 pivotal Investigational Device Exemption (IDE) completed comprehensive evaluations at 12 months postactivation, 3 years postactivation, and then as part of a postapproval study at 5 years postactivation. Testing included audiometric, speech perception, and subjective satisfaction measures.
Mean unilateral speech perception performance was significantly improved at all postoperative intervals compared to preoperative best-aided results and has remained stable to 5 years postactivation. Ninety-four percent of subjects had measurable hearing, and 72% continued to use electric-acoustic stimulation in the implanted ear after 5 years of implant use. Subjective satisfaction results support objective performance improvements.
Results demonstrate long-term success of patients with high-frequency hearing loss following Hybrid L24 (Cochlear) cochlear implantation. Benefits include speech perception abilities significantly better than those in the preoperative best-aided condition, with additional benefit in those using electric-acoustic stimulation in the implanted ear.
2b. Laryngoscope, 1939-1945, 2018.
为证明植入对高频感音神经性听力损失患者的长期益处，本报告对一组植入者进行了5年随访，这些植入者是Cochlear™ Nucleus Hybrid™ L24植入系统关键临床研究的受试者。
汇总三项相关临床研究的结果，以提供一组术前有高频听力损失且植入了Nucleus Hybrid L24（澳大利亚悉尼Cochlear有限公司）人工耳蜗的受试者在植入人工耳蜗1年、3年和5年后的结局数据。参与Hybrid L24关键研究性器械豁免（IDE）的50名成年受试者中的一个子集（N = 32）在开机后12个月、开机后3年，然后作为上市后研究的一部分在开机后5年完成了全面评估。测试包括听力测定、言语感知和主观满意度测量。
与术前最佳助听结果相比，所有术后随访期的平均单侧言语感知表现均有显著改善，并且在开机后5年一直保持稳定。94%的受试者有可测量的听力，72%的受试者在植入人工耳蜗5年后仍继续在植入耳使用电声刺激。主观满意度结果支持客观性能的改善。
结果证明高频听力损失患者在植入Hybrid L24（Cochlear）人工耳蜗后取得了长期成功。益处包括言语感知能力明显优于术前最佳助听状态，并且在植入耳使用电声刺激的患者中还有额外益处。
2b。《喉镜》，1939 - 1945页，2018年。
